# K231216: Potenza

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Dec 10, 2024 after 592 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 263 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201685: Potenza, Jeisys Medical, Inc. (2021) Summary page 5.

## Most influential descendants
- K242469: RFMagik Lite (2025), 2 descendants of its own
- K254185: Potenza Prime (2026), 0 descendants of its own
- K250217: AGNES Ultra (2025), 0 descendants of its own
- K243713: Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) (2025), 0 descendants of its own

## Indications for use
The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K231216
Methodology: https://510kreport.com/methodology